US-MA-Bedford: Senior Quality Assurance Compliance Specialist in biotech

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Date: 13-Jan-2009

Senior Quality Assurance Compliance Specialist in biotech

This position is responsible for completing a variety of Quality Assurance activities in support of the manufacturing operations. Specific responsibilities will include review of batch records, product release, and providing QA input on the production floor. Other areas of activity will include internal auditing and other duties which ensure compliance with current regulations.

Responsible for review of batch records to meet product release requirements * Coordinate with Manufacturing Management to answer questions within the record review process * Prepare documents for final product release and recommend release to QA Management * Provide review for various documents for compliance with current regulations * Provide information and support to Production line management * Perform internal audits as required

The position requires a Bachelors Degree in the life sciences with 5-7 years industry experience. Knowledge of GMP/ISO requirements, specifically ISO 13485 Medical Devices and ISO 9001-2000 is required. Knowledge and experience in 21 CFR Part 11 is preferred. Previous experience in a cGMP manufacturing environment also required. Demonstrated proficiency in word processing, spreadsheets and databases is required. Presentation, communication skills and the ability to interact positively and professionally with customers is required.

To apply for this position, please visit this Website.

Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/